Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
The Limited Output Transcutaneous Electrical Nerve Stimulator for Arthritis Pain Relief (product code OCF) is a neurological device that delivers electrical stimulation to nerves for relief of pain associated with arthritis, including both osteoarthritis and rheumatoid arthritis. The device is transcutaneous (applied to the skin surface) and is designed with a limited output to ensure safe stimulation levels. This device is FDA Class 2 under regulation 882.5890 in the Neurology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCF
- Device Class
- FDA class 2
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900759 | POLY-OP (TM) | May 24, 1990 | Substantially Equivalent | Nu-Gyn-Tek, Inc. |